@article{Gargano2018-fq,

title = {Efficacy and tolerability outcomes of a phase II, randomized,  open-label, multicenter study of a new water-dispersible  pediatric formulation of dihydroartemisinin-piperaquine for the  treatment of uncomplicated Plasmodium falciparum malaria in  African infants},

author = {Nicola Gargano and Lola Madrid and Giovanni Valentini and Umberto D'Alessandro and Tinto Halidou and Sodiomon Sirima and Antoinette Tshefu and Ali Mtoro and Samwel Gesase and Eurartesim Dispersible Study Group and Quique Bassat},

doi = {10.1128/AAC.00596-17},

issn = {1098-6596 0066-4804},

year  = {2018},

date = {2018-01-01},

urldate = {2018-01-01},

journal = {Antimicrob. Agents Chemother.},

volume = {62},

number = {1},

abstract = {Artemisinin combination therapies are considered the mainstay of 

 malaria treatment, but pediatric-friendly formulations for the 

 treatment of infants are scarce. We sought to evaluate the 

 efficacy and safety of a new dispersible-tablet formulation of 

 dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison 

 to the marketed tablet (Eurartesim) in the treatment of infants 

 with uncomplicated Plasmodium falciparum malaria. Reported here 

 are the results of a large phase II, randomized, open-label, 

 multicenter trial conducted in African infants (6 to 12 months of 

 age) from Mozambique, Burkina Faso, The Gambia, the Democratic 

 Republic of the Congo, and Tanzania. Primary efficacy endpoint 

 was the PCR-corrected adequate clinical and parasitological 

 response (ACPR) at day 28. Analysis was performed for the 

 intention-to-treat (ITT) and per-protocol (PP) populations. A 

 total of 201 patients received the dispersible-tablet 

 formulation, and 99 received the conventional one administered as 

 crushed tablets. At day 28, the PCR-corrected ACPRs were 86.9% 

 (ITT) and 98.3% (PP) in the dispersible-tablet group and 84.9% 

 (ITT) and 100% (PP) in the crushed-tablet group. At day 42, 

 these values were 85.9% (ITT) and 96.5% (PP) in the 

 dispersible-tablet group and 82.8% (ITT) and 96.4% (PP) in the 

 crushed-tablet group. The comparison between survival curves for 

 time to new infections showed no statistically significant differences (P = 0.409). The safety and tolerability profile for 

 the two groups was similar in terms of type and frequency of 

 adverse events and was consistent with that expected in African 

 infants with malaria. A standard 3-day treatment with the new 

 dispersible DHA/PQP formulation is as efficacious as the 

 currently used tablet in African infants and has a comparable 

 safety profile. (This trial was registered at ClinicalTrials.gov 

 under registration no. NCT01992900.).},

keywords = {Africa; antimalarial agents; dihydroartemisinin-piperaquine;   infants; malaria},

pubstate = {published},

tppubtype = {article}

}